displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Clonazepam, a benzodiazepine, is available as scored tablets debossed with “1” and “2” containing 0.5 mg of clonazepam and unscored tablets debossed with “C 1” on 1 mg tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of clonazepam. Each tablet contains anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch (corn), with the following colorants: 0.5 mg-FD&C Yellow No. 6 Lake and 1 mg- FD&C Blue No.2 Lake.
Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Clonazepam should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows:
Bottles of 30 NDC 63187-603-30
Bottles of 60 NDC 63187-603-60
Bottles of 90 NDC 63187-603-90
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].
Accord Healthcare, Inc.,
1009, Slater Road,
Durham, NC 27703,
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
Proficient Rx LP
Thousand Oaks, CA 91320
10 7744 1 626035
Issued October, 2010.
PRINCIPAL DISPLAY PANEL – 0.5 mg
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Pharmacist: Must be dispensed with Medication Guide.